Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

NCT01917032 | Unknown Phase 3

• 1 other identifier: SPRINK001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries. Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013? Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group. Design: Randomized clinical trial, triple-blind and placebo-controlled. Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu. Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo. Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).

Conditions

Malnutrition

Keywords

Trace Elements; Preschool; Malnutrition; Fortified Food

Outcome Measures

Primary Outcomes (1)

• Hemoglobin

  Hemoglobin quantitation for laboratory tests (g/dl)

  10 weeks

Secondary Outcomes (1)

• Transferrin

  10 weeks

Other Outcomes (1)

• Child Growth Indicators

  10 weeks

Study Arms (2)

Sprinkles

ACTIVE COMPARATOR

Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks

Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food

Placebo

PLACEBO COMPARATOR

Maltodextrin 1 gram orally on weekdays during 11 weeks

Dietary Supplement: placebo

Interventions

Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food DIETARY_SUPPLEMENT

1 g orally on weekdays during 11 weeks

Also known as: Chispitas, Sprinkles

Sprinkles

placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 5 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Assistance to children's centres full day (8 hours).
• Age 5 to 59 months.

You may not qualify if:

• Anemia (hemoglobin less than 11 g / dl).
• Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.
• Denial for informed consent signing by parents or legal guardians.
• Diagnosis of severe acute malnutrition by anthropometric measurements.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Fundación de Atención a la Niñez (FAN)

Medellín, Ant, 0574, Colombia

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Iron; Zinc; Folic Acid; Vitamin A

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Cristian Vargas, MD

  CES University

  PRINCIPAL INVESTIGATOR

• Juliana Orozco, Nutricionist

  CES University

  PRINCIPAL INVESTIGATOR

• Juliana Sánchez, Dentist

  CES University

  STUDY CHAIR

• Liliana Montoya, Epidemiology

  CES University

  STUDY DIRECTOR

• Javier Chica, Veterinarian

  CES University

  STUDY CHAIR

• Maylen Rojas, Epidemiology

  CES University

  STUDY CHAIR

• Óscar Villada, MD

  CES University

  STUDY CHAIR

• Alejandro Díaz, Pediatrist

  CES University

  STUDY CHAIR

Central Study Contacts

Cristian Vargas, MD

CONTACT

573006099044; crivargas24@hotmail.com

Juliana Orozco, Nutritionist

CONTACT

573205371487; julianaorozcocano@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 6, 2013

Record last verified: 2013-08

Locations

CO (1)